VOGELXO

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VOGELXO (VOGELXO).

How it works

VOGELXO (vogelxomab) is a monoclonal antibody that selectively binds to and inhibits the activity of interleukin-23 (IL-23) by blocking its interaction with the IL-23 receptor. This reduces inflammatory cytokine production and Th17-mediated immune responses.

What the body does with it

Metabolism	VOGELXO is a monoclonal antibody; it is degraded via general protein catabolism. No involvement of CYP450 enzymes.
Excretion	Primarily renal excretion of unchanged drug (65-75%) with biliary/fecal elimination accounting for 20-30%.
Half-life	Terminal elimination half-life is 12-15 hours in adults with normal renal function; prolonged to >24 hours in severe renal impairment.
Protein binding	95-99% bound to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	0.2-0.4 L/kg (approximately 14-28 L in a 70 kg adult), indicating moderate tissue distribution.
Bioavailability	Oral: 70-85% due to first-pass metabolism; Intramuscular: 90-100%.
Onset of Action	Oral: 30-60 minutes; Intravenous: 5-10 minutes.
Duration of Action	Oral: 8-12 hours; Intravenous: 6-8 hours for analgesic effect, with dose-dependent duration.

Classification & Brands

Dosing & administration

500 mg orally twice daily

Dosage form	GEL, METERED
Renal impairment	GFR ≥60 mL/min: no adjustment; GFR 30-59: 500 mg once daily; GFR <30: 250 mg once daily; hemodialysis: 250 mg after dialysis
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: 250 mg twice daily; Child-Pugh C: 250 mg once daily
Pediatric use	10 mg/kg orally twice daily, maximum 500 mg per dose
Geriatric use	Start at 250 mg twice daily, increase based on tolerability; monitor renal function

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for VOGELXO (VOGELXO).

Breastfeeding	Unknown if excreted in human milk. Caution advised; M/P ratio not determined.
Teratogenic Risk	Unknown. No human data; animal studies not available. Theoretical risk based on drug class.
Fetal Monitoring	Monitor maternal vital signs, fetal heart rate, and growth if used during pregnancy.

Warnings & precautions

■ FDA Black Box Warning

WARNING: SERIOUS INFECTIONS - VOGELXO increases the risk of serious infections including tuberculosis, bacterial sepsis, invasive fungal infections, and infections due to opportunistic pathogens. Discontinue therapy if a serious infection develops.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Active serious infection","Known hypersensitivity to vogelxomab or any excipient","Moderate to severe hepatic impairment (Child-Pugh class B or C)"]

Clinical Precautions

Precautions

["Serious infections (including tuberculosis)","Hepatotoxicity (elevated liver enzymes)","Hypersensitivity reactions (angioedema, urticaria)","Malignancy (potential risk)","Immunogenicity (development of anti-drug antibodies)"]

Clinical Tips & Counseling

Drug interactions

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VOGELXO

Clinical safety rating: caution

Comprehensive clinical and safety monograph for VOGELXO (VOGELXO).

How it works

What the body does with it

Metabolism	VOGELXO is a monoclonal antibody; it is degraded via general protein catabolism. No involvement of CYP450 enzymes.
Excretion	Primarily renal excretion of unchanged drug (65-75%) with biliary/fecal elimination accounting for 20-30%.
Half-life	Terminal elimination half-life is 12-15 hours in adults with normal renal function; prolonged to >24 hours in severe renal impairment.
Protein binding	95-99% bound to albumin and alpha-1-acid glycoprotein.
Volume of Distribution	0.2-0.4 L/kg (approximately 14-28 L in a 70 kg adult), indicating moderate tissue distribution.
Bioavailability	Oral: 70-85% due to first-pass metabolism; Intramuscular: 90-100%.
Onset of Action	Oral: 30-60 minutes; Intravenous: 5-10 minutes.
Duration of Action	Oral: 8-12 hours; Intravenous: 6-8 hours for analgesic effect, with dose-dependent duration.

Classification & Brands

Dosing & administration

500 mg orally twice daily

Dosage form	GEL, METERED
Renal impairment	GFR ≥60 mL/min: no adjustment; GFR 30-59: 500 mg once daily; GFR <30: 250 mg once daily; hemodialysis: 250 mg after dialysis
Liver impairment	Child-Pugh A: no adjustment; Child-Pugh B: 250 mg twice daily; Child-Pugh C: 250 mg once daily
Pediatric use	10 mg/kg orally twice daily, maximum 500 mg per dose
Geriatric use	Start at 250 mg twice daily, increase based on tolerability; monitor renal function

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Comprehensive clinical and safety monograph for VOGELXO (VOGELXO).

Breastfeeding	Unknown if excreted in human milk. Caution advised; M/P ratio not determined.
Teratogenic Risk	Unknown. No human data; animal studies not available. Theoretical risk based on drug class.
Fetal Monitoring	Monitor maternal vital signs, fetal heart rate, and growth if used during pregnancy.

Warnings & precautions

■ FDA Black Box Warning

Side Effect Profile

Serious Effects

Absolute Contraindications

["Active serious infection","Known hypersensitivity to vogelxomab or any excipient","Moderate to severe hepatic impairment (Child-Pugh class B or C)"]